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3 INTRODUCTION Researchers and clinicians are making remarkable progress in the fight against cancer; death rates have declined overall and for many patients, cancer has become a chronic condition to be managed, instead of a death sentence. However, the many different forms of cancer still cause enormous suffering for patients and their families and a substantial economic burden in the United States. To sustain continued progress in an environment of increasing pressure to contain health care costs, it is important to understand the valuable role new medicines play in improving patient outcomes. 1

4 1 ADVANCES IN CANCER TREATMENT Cancer Medicines Are Benefiting Patients In recent decades we have seen remarkable progress in the fight against cancer. Research has advanced from viewing cancer as a monolithic disease to understanding it better on a molecular and genomic level. With this greater understanding has come better treatments that have helped to lengthen lives, improve patients quality of life, and increase productivity. Patients today have better options than ever before. 1 Advances in Treatment 2

5 Five-Year Survival is Increasing for Many Types of Cancer The chances that a cancer patient will live 5 years or more has increased by 39% across cancers. 100% 5-Year Survival Rates for Selected Cancers, % 60% 40% 20% % of survival gains in cancer are attributable to new treatments including medicines. 0% Breast Cancer Prostate Cancer Colon/Rectum Lung/Bronchus 1 Advances in Treatment 3

6 Steady Decline in Cancer Death Rates According to the American Cancer Society, improvements in treatment are contributing to increases in cancer survival. Percent Change by Decade in U.S. Death Rates from Cancer 4% 4.7% 3.9% -1% -6% -7.6% -11% -16% -15.5% Advances in Treatment 4

8 The Number of Cancer Survivors is Steadily Rising The continued increase in survival rates is in large part attributable to earlier detection and better treatments. U.S. Cancer Survivors Over Time, Millions Remarkable advances are contributing to the rise in the number of people who are surviving longer and living life to the fullest after their cancer diagnosis. American Association for Cancer Research million 9.8 million 13.7 million Advances in Treatment 6

9 Understanding the Value of Innovation: Evolution over Time Cancer medicines often deliver more value than initial studies show. Cancer medicines often go on to deliver more value than initial studies show. FDA approval and introduction of a new therapy is a significant milestone for patients but it is only the beginning. Our knowledge of the full benefits of a therapy emerges over time, through continued research and real world clinical practice. Possible pathways for value to reveal itself over time: Earlier Use Use in combination with other agents Use in specific sub-populations of patients using diagnostics Use in other disease indications Incremental advances can add up to transformative changes. Siddhartha Mukherjee, MD, author of The Emperor of All Maladies 1 Advances in Treatment 7

10 Chronic Leukemias: Increased Survival Rates When imatinibwas first approved in 2001 to treat chronic myeloid leukemia (CML), the full value of the medicine had not been completely realized. After initial approval, continued research revealed that imatinibhad an even greater impact when initiated earlier in the progression of the disease. Further research also revealed that imatinibwas effective in combating other devastating forms of leukemia, as well as gastrointestinal stromal tumors. Today, survival rates have improved dramatically and CML patients are living close to normal life spans. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 5-Year Survival Rates for CML Patients 31% 89% 0% Prior to Introduction of Imatinib After Introduction of Imatinib 1 Advances in Treatment 8

11 Clinical Value Evolves Over Time: Trastuzumab Trastuzumabwas originally approved by the FDA in 1998 to treat metastatic breast cancer in patients whose tumors expressed the HER2 protein. Approval was based on data showing that treatment slowed disease progression but long term survival data was unknown data showed that median overall survival increased by 25% with the addition of trastuzumab. In 2008, the benefit of earlier treatment initiation was proven, giving trastuzumaban additional indication as early adjuvant therapy for breast cancer. Subsequent indications for use in combination to treat other types of gastric and gastroesophagealcancers followed. Use in Combination with Other Agents or Biomarkers Use in Different Disease Indications Use Earlier in treatment line/disease state Use in initial FDA Approved Indication Additional Value is Revealed Over Time Launch: Advances in Treatment 9

12 The Role of Personalized Medicines Has Grown in the Last Decade Personalized medicines provide effective and efficient care by targeting the right medicine to the right patient. Oncology Treatment Modalities in Top Pharmaceutical Markets, % 46% Targeted Supportive Care Cytotoxics Hormonals 1 Advances in Treatment 10

13 2 MEDICINES IN DEVELOPMENT Discovery and Development of Cancer Medicines The R&D process remains challenging and expensive but advances in basic science have opened new doors for biopharmaceutical researchers. More than 1,000 new cancer medicines are in clinical development in the U.S. These medicines represent a wide range of novel approaches. Patients today have more reason to hope than ever before. 2 Medicines in Development 11

14 More than 1,000 Medicines in Development for Various Cancers Breast Cancer Colorectal Cancer Lung Cancer Lymphoma Number of Medicines in Development in 2014, Selected Cancer Types* Scientifically, we have never been in a better position to advance cancer treatment. We now understand many of the cellular pathways that can lead to cancer. We have learned how to develop drugs that block these pathways. Prostate Cancer Skin Cancer Richard L. Schilsky, MD, Professor, University of Chicago *Some medicines are being explored in more than one therapeutic category. 2 Medicines in Development 12

15 The Majority of Cancer Medicines in the Pipeline Would be New Approaches to Targeting Selected Cancers Researchers are using novel approaches to attack cancer at the molecular level. An average of 80% of drugs in the oncology pipeline may be first-in-class medicines. Percentage of Projects in Development that Are Potentially Novel Approaches in Selected Cancer Areas, 2011 Bladder cancer Blood cancers Breast cancer Colorectal cancer Lung cancer 75% 77% 76% 81% 75% Melanoma 91% Prostate cancer Cancer, general 75% 80% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2 Medicines in Development 13

16 Personalized Medicine is Transforming Cancer Care Biopharmaceutical companies are focused in this area resulting in several recent approvals and a growing number of new medicines in the pipeline % Of new drugs in the pipeline are reportedly personalized medicines (across all diseases) Oncology is on fire with [personalized medicine], with treatment selections based on individual molecular characteristics. This is also happening with chronic infectious diseases, and genetic diseases are not far behind. Janet Woodcock, Director Center for Drug Evaluation and Research, U.S Food and Drug Administration 2 Medicines in Development 14

17 3 VALUE AND SPENDING Understanding the Value of Cancer Medicines New cancer medicines bring great value to patients and the health care system. It is important to view cancer spending in the context of health care spending overall. Likewise, cancer medicines are a crucial part of oncology treatment but represent just a small portion of cancer costs. 3 Spending and Costs 15

20 Average Price Growth of Cancer Drugs in Medicare Part B Less than Medical Inflation The trend of volume-weighted Average Sales Price (ASP) for cancer drugs administered through Medicare Part B has been growing more slowly than overall medical inflation *Total retail sales including brand medicines and generics. 3 Spending and Costs 18

22 Substantial Gains to Society from Advances in Cancer Treatment = Years of life saved due to cancer treatment advances, = Value of improved cancer treatment to society based on improved productivity, extended life and other factors, Spending and Costs 20

23 Deaths Per 100,000 Population Innovations in Cancer Treatment Could Echo HIV/AIDS Successes As HIV/AIDS treatments improved, spending became more sustainable Annual Number of AIDS Deaths in the United States 1996: HAART becomes widely available We used to think HIV costs would overwhelm us.but we figured it out and let drug development progress similarly, cancer care will evolve. Ira Klein, M.D., M.B.A., FACP, Aetna Remember HIV?... thanks to a wave of new discoveries that came both from academic centers and the pharmaceutical industry, the HIV crisis was transformed into a stable condition which is managed very differently by society where good drugs are available. They are controlling the disease, and society has been saving an enormous amount of money as a result of these innovative drugs by providing better care out of hospitals. Hervé Hoppenot, President, Incyte Pharmaceuticals 3 Spending and Costs 21

24 Fostering Innovation At a time when the scientific promise is greater than ever, we must find ways to promote innovation while also addressing health care costs. Coverage and payment policies that support and encourage medical innovation Value assessments that align with innovation A well-functioning, science-based regulatory system Strong intellectual property protections By bringing the stakeholder community together, stimulating dialogue, and communicating with policymakers, we are optimistic that continued scientific progress toward solutions to long-term human and economic challenges can be realized within regulatory and policy frameworks that incentivize innovation and value in healthcare. A. Abernethy, et al. Clinical Cancer Research There is no question that when we talk about turning the tide against cancer, the most exciting opportunities, the new opportunities in fact, are understanding the biology and applying that biology to new treatments. We are certainly at a turning point. J. Leonard Lichtenfeld, M.D., American Cancer Society 4 Conclusion 22

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